(Sharecast News) - Speciality pharmaceutical company Diurnal Group narrowed its first-half loss by 53% to ?4.6m, it announced on Tuesday, which it said reflected improved revenues and a reduction in clinical development expenses for the period.
The AIM-traded firm said revenues from 'Alkindi' totalled ?1.1m for the six months ended 31 December, representing 516% year-on-year growth.
Held-to-maturity financial assets, cash and cash equivalents as at period end totalled ?4.6m, down from ?6.9m a year earlier and ?9.1m at the start of the six-month period.
On the operational front, looking at Alkindi, which consists of hydrocortisone granules in capsules for opening, launches occurred in Sweden, Denmark, Norway and Iceland with partner Frost Pharma during the period, following initial launches in the UK, Germany and Austria.
It subsequently launched in Italy, post-period end.
A new drug application for Alkindi was submitted to the US Food and Drug Administration (FDA) during the half-year, with partnering discussions for Alkindi and 'Chronocort' said to be ongoing in the United States.
Diurnal also submitted a marketing authorisation application in Australia, following the grant of orphan drug designation there.
Looking at its Chronocort product, which is modified release hydrocortisone, Diurnal submitted a marketing authorisation application to the European Medicines Agency (EMA), along with an application for confirmation of orphan drug status.
Finally, with its Ditest product, which is a native oral testosterone formulation, Diurnal received headline results from the phase 1 proof-of-concept clinical trial in target hypogonadal patients during the half-year/
It said there was potential for Ditest to be the first effective oral native testosterone treatment in an estimated $4.8bn global market.
"Diurnal has continued to experience strong commercial traction for Alkindi, with robust growth in sales," said chief executive officer Martin Whitaker.
"Further Alkindi launches are planned for 2020 in Europe, in addition to the recent launch in Italy.
"We also delivered on two major regulatory milestones, filing both the US new drug application for Alkindi and the European marketing authorisation application for Chronocort submissions during the fourth quarter."
Whitaker said the company was expecting US regulatory approval for Alkindi in the fourth quarter of 2020, and European regulatory approval for Chronocort in the first quarter of 2021.
"There also continues to be strong interest in Alkindi and Chronocort from potential US partners and we expect to conclude a US licensing deal in the first half of 2020.
"During the period, Diurnal also announced positive phase 1 clinical data from its oral native testosterone product, Ditest, adding a potentially valuable clinical-stage product to its expanding endocrinology-focused pipeline.
"Diurnal believes that it is strongly positioned to capitalise on the progress with its pipeline and to secure funding for the next stage of its development into a world-leading endocrinology specialty pharma company."
At 1335 GMT, shares in Diurnal were down 2.4% at 24.4p.
2 Dec 2019 13:19
Diurnal submits application for 'Alkindi Sprinkle' to US FDA
(Sharecast News) - Specialty pharmaceutical company Diurnal Group has submitted a 'New Drug Application' (NDA) to the US Food and Drug Administration (FDA), for the regulatory approval of 'Alkindi Sprinkle', or hydrocortisone granules in capsules for opening, as a replacement therapy of adrenal insufficiency in infants, children and adolescents in the US, it announced on Monday.
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